The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for B-system Silicone.
| Device ID | K982917 |
| 510k Number | K982917 |
| Device Name: | B-SYSTEM SILICONE |
| Classification | Material, Impression |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-19 |
| Decision Date | 1998-10-16 |
| Summary: | summary |